Trial · NCT01782443

Ziv-Aflibercept for Advanced Progressive Carcinoid Tumors

NCT01782443, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2022-11-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Ziv-Aflibercept for Advanced Progressive Carcinoid Tumors. Trials, record NCT01782443. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01782443

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Ziv-Aflibercept for Advanced Progressive Carcinoid Tumors
NCT number: NCT01782443
Status: Completed
Phases: Phase 2
Enrollment: 19 participants, actual
Lead sponsor: Dana-Farber Cancer Institute
Conditions: Carcinoid Tumor
Interventions: Ziv-aflibercept
First posted: 2013-02-01
Last updated: 2023-08-14
Results first posted: 2022-11-09

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression Free Survival	2 years	To evaluate the progression-free survival (PFS) duration of patients with metastatic, unresectable, progressive carcinoid tumors treated with Ziv-aflibercept. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) was used. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study with at least a 5 mm absolute increase in the sum of all lesions. The appearance of one or more new lesions denotes disease progression. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Secondary	Evaluation of Disease Response	2 years	To evaluate disease response using RECIST criteria, version 1.1, of patients with advanced carcinoid tumors treated with Ziv-aflibercept. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT include the following categories of disease response: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable disease (SD), less than 30% decrease but no more than 20% increase in sum of the longest diameter of target lesions.
Secondary	Evaluation of Biochemical Response - Number of Patients With Greater Than 50% Drop in Chromogranin A From Baseline	2 years	To evaluate biochemical response in patients with elevated chromogranin A at baseline, using levels of chromogranin-A measured at baseline and following treatment with Ziv-aflibercept. Biochemical response was defined as greater than 50% drop in chromogranin A from baseline. During the screening period, all patients were evaluated for serum chromogranin A. Per protocol, if results of these are normal at baseline, they were not repeated while on study. If above institutional ULN at baseline, they were evaluated at time of tumor restaging.
Secondary	Biochemical Response - Number of Patients With Greater Than 50% Drop in 24hr Urine 5-HIAA From Baseline	2 years	To evaluate biochemical response in patients with elevated 24hr urine 5-HIAA at baseline, using levels of 24hr urine 5-HIAA at baseline and following treatment with Ziv-aflibercept. Biochemical response was defined as greater than 50% drop in 24hr urine 5-HIAA from baseline. During the screening period, all patients were evaluated for 24hr urine 5HIAA. Per protocol, if results of these were normal at baseline, they were not repeated while on study. If above institutional ULN at baseline, they were evaluated at time of tumor restaging.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression Free Survival	2 years	The efficacy of ziv-aflibercept was evaluated amongst all patients who were treated on protocol (4 mg/kg in 10 patients, reduced to 2 mg/kg in 9 patients due to adverse events observed at the higher does level).	months	MEDIAN
SECONDARY	Evaluation of Disease Response	2 years	14 patients were evaluated for disease response per RECIST 1.1. The remaining 5 patients were not evaluable for response by RECIST 1.1 because they did not undergo protocol restaging due to early withdrawal from the study prior to reaching first protocol restaging.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Evaluation of Biochemical Response - Number of Patients With Greater Than 50% Drop in Chromogranin A From Baseline	2 years	12 participants were evaluable based on baseline assessment of serum chromogranin A. These patients were evaluated for a greater than 50% drop in chromogranin A from baseline while on treatment.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Biochemical Response - Number of Patients With Greater Than 50% Drop in 24hr Urine 5-HIAA From Baseline	2 years	11 patients were evaluable based on baseline assessment of 24hr urine 5-HIAA. These patients were followed for greater than 50% drop in 24hr urine 5-HIAA after starting treatment.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group5

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Progression Free Survival	Experimental Treatment Arm (Ziv-aflibercept)		11.8	95% Confidence Interval 3.2 to 16.1	months
Evaluation of Disease Response	Experimental Treatment Arm (Ziv-aflibercept)	Partial Response	1		Participants
Evaluation of Disease Response	Experimental Treatment Arm (Ziv-aflibercept)	Stable Disease	13		Participants
Evaluation of Biochemical Response - Number of Patients With Greater Than 50% Drop in Chromogranin A From Baseline	Experimental Treatment Arm (Ziv-aflibercept)		2		Participants
Biochemical Response - Number of Patients With Greater Than 50% Drop in 24hr Urine 5-HIAA From Baseline	Experimental Treatment Arm (Ziv-aflibercept)		1		Participants

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Experimental Treatment Arm (Ziv-aflibercept)	19
Overall Study	COMPLETED	Experimental Treatment Arm (Ziv-aflibercept)	19
Overall Study	NOT COMPLETED	Experimental Treatment Arm (Ziv-aflibercept)	0

Source ClinicalTrials.gov

Adverse events48

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anemia	Blood and lymphatic system disorders	Ziv-aflibercept 4mg/kg	2	10
other	Anemia	Blood and lymphatic system disorders	Ziv-aflibercept 2mg/kg	0	9
other	Anorexia	General disorders	Ziv-aflibercept 4mg/kg	2	10
other	Anorexia	General disorders	Ziv-aflibercept 2mg/kg	2	9
other	diarrhea	Gastrointestinal disorders	Ziv-aflibercept 4mg/kg	1	10
other	diarrhea	Gastrointestinal disorders	Ziv-aflibercept 2mg/kg	1	9
other	fatigue	General disorders	Ziv-aflibercept 4mg/kg	5	10
other	fatigue	General disorders	Ziv-aflibercept 2mg/kg	3	9
other	hypertension	Cardiac disorders	Ziv-aflibercept 4mg/kg	9	10
other	hypertension	Cardiac disorders	Ziv-aflibercept 2mg/kg	9	9

1 to 10 of 48Source ClinicalTrials.gov

See all 48 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ziv-aflibercept 4mg/kg	1	10
Total, all-cause mortality	Ziv-aflibercept 2mg/kg	0	9
Total, other adverse events	Ziv-aflibercept 4mg/kg	10	10
Total, other adverse events	Ziv-aflibercept 2mg/kg	9	9
Total, serious adverse events	Ziv-aflibercept 4mg/kg	5	10
Total, serious adverse events	Ziv-aflibercept 2mg/kg	5	9

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36395401	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Ziv-aflibercept 4mg/kg vs Ziv-aflibercept 2mg/kg: deaths from any cause	Trial comparisons
Ziv-aflibercept 4mg/kg vs Ziv-aflibercept 2mg/kg: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01782443

GET https://conductscience.org/api/trials/v1/NCT01782443/events?page=2

API reference For AI assistants